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Novartis, GSK, Sanofi, BMS shell out over US$ 10 bn in dealmaking, as mid-size deals take centerstage in 2024

The world of pharmaceuticals and biotechnology continued to evolve this year with strategic alliances reshaping industry contours. With mid-size deals taking centerstage, the growth trajectory appears to be marked by a balance of both caution and calculated ambition.The deal-making environment was robust in 2023, with over 2,000 unique pharma and biotech deals totaling more than US$ 410 billion, according to the PharmaCompass database. Last year, there were over 200 mergers and acquisitions (M&As) with transactions exceeding US$ 160 billion in total value. Oncology, infections and infectious diseases, and neurology had emerged as the top three therapeutic areas for deals.PharmaCompass’ analysis indicates that the momentum has been maintained in 2024. As of August 6, the industry had seen over 1,200 unique deals valued at more than US$ 230 billion, including over 120 M&A transactions surpassing US$ 60 billion in aggregate value. While oncology maintains its lead position, neurology and immunology have gained notable traction.The one big difference is that 2024 is yet to witness a mega-deal, comparable to Pfizer’s US$ 43 billion acquisition of Seagen in 2023 or Amgen’s US$ 27.8 billion Horizon buyout announced in 2022. The largest transaction thus far has been Novo Nordisk Foundation’s US$ 16.5 billion acquisition of Catalent, a contract development and manufacturing organization (CDMO).This compilation does not include deals related to acquisition of facilities, divestment, medical devices, diagnostics and animal health. We have considered deals announced, irrespective of when these transactions were completed. For a comprehensive overview of CDMO deals and developments in 2024, please refer to our dedicated roundup.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Vertex buys Alpine Immune for US$ 4.9 bn; Gilead’s CymaBay buyout pays off via FDA nodAmongst the biggest acquisitions of 2024 was Vertex Pharmaceuticals’ buyout of Alpine Immune Sciences for US$ 4.9 billion. It granted Vertex access to protein-based immunotherapies, including the promising povetacicept for IgA nephropathy, a serious kidney disease.Gilead Sciences’ acquisition of CymaBay Therapeutics for US$ 4.3 billion in February secured it access to seladelpar (Livdelzi), an experimental drug that received FDA’s accelerated approval this month for primary biliary cholangitis, a liver disease that affects the bile ducts. Eli Lilly bolstered its presence in the US$ 26.65 billion inflammatory bowel disease (IBD) market by purchasing Morphic Holding for approximately US$ 3.2 billion in July. Through this deal, Lilly gained the oral IBD therapy candidate MORF-057, which will offer a more convenient dosing option compared to injectable drugs currently available in the market. Lilly sees the IBD space as a way to diversify beyond obesity.Merck expanded its ophthalmology portfolio by acquiring Eyebiotech Limited for US$ 1.3 billion (plus US$ 1.7 billion in milestone payments), obtaining Restoret for diabetic macular edema and neovascular age-related macular degeneration.Japanese drugmaker Ono Pharmaceutical acquired Deciphera Pharmaceuticals for US$ 2.4 billion, gaining Qinlock for gastrointestinal stromal tumors and vimseltinib for tenosynovial giant cell tumors. Sanofi targeted rare diseases by purchasing Inhibrx for up to US$ 2.2 billion. The acquisition gave the French drugmaker access to INBRX-101 for Alpha-1 antitrypsin deficiency, a genetic condition that can cause lung and liver damage.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Novartis buys two oncology firms for their assets; J&J, Genmab join ADC bandwagonNovartis has been on a shopping spree, and has made two significant purchases this year. First, it acquired MorphoSys for € 2.7 billion (US$ 2.9 billion), thereby adding the promising bone-marrow cancer treatment pelabresib to its pipeline. Second, it announced the acquisition of Mariana Oncology for US$ 1 billion upfront (plus US$ 750 million in milestone payments), thereby expanding into radioligand therapies (RLTs) to treat cancers with high unmet need. RLTs take a targeted approach, delivering radiation to the tumor, while limiting damage to the surrounding cells.AstraZeneca entered the field of radioconjugates, which is a promising modality in the treatment of cancer, by acquiring Fusion Pharmaceuticals for US$ 2.4 billion.In January this year, Johnson & Johnson had announced the acquisition of antibody-drug-conjugate (ADC) developer Ambrx Biopharma for about US$ 2 billion. With this buyout, J&J has joined the likes of Bristol Myers Squibb, AbbVie and GSK who had entered this promising field through acquisitions last year.Similarly, Denmark’s Genmab bought ProfoundBio for US$ 1.8 billion in cash, boosting its oncology portfolio with three next-generation ADC candidates. This includes Rina-S, which recently received FDA’s fast track designation for the treatment of ovarian cancer.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Novartis signs multiple collaborations; GSK, Takeda, AbbVie sign billion-dollar dealsNovartis was not just busy signing M&A deals, it also signed a bevy of collaboration agreements. For instance, Shanghai-based Argo partnered Novartis on two early-stage RNA interference candidates for cardiovascular diseases, potentially earning the former up to US$ 4.2 billion plus tiered royalties.Novartis also agreed to pay up to US$ 3 billion (including US$ 150 million upfront) to Dren Bio to use the latter’s Targeted Myeloid Engager and Phagocytosis platform to develop bispecific antibodies to treat cancer.Moreover, the Swiss drugmaker expanded its peptide discovery collaboration with Japan-based PeptiDream in a deal worth over US$ 2.71 billion in milestone payments, plus an upfront payment of US$ 180 million. Peptide-drug conjugates (PDCs) are the next generation of targeted therapeutic drugs after ADCs and Novartis is, thus far, the only big pharma with FDA-approved radioligand PDCs. GSK entered a groundbreaking partnership with Flagship Pioneering, potentially worth over US$ 7 billion, to identify and develop 10 novel drugs and vaccines. The deal, starting with respiratory and immunology drugs, involves US$ 720 million in upfront and milestone payments for each candidate. This collaboration leverages Flagship’s extensive portfolio of over 40 biopharma companies with drug development capabilities.There were two significant deals in the field of neuroscience. First, Takeda said it is paying Swiss biotech AC Immune US$ 100 million upfront with potential further payments of US$ 2.1 billion for an exclusive option to license global rights to an Alzheimer’s vaccine and related immunotherapies.Second, AbbVie and clinical stage biotech Gilgamesh Pharmaceuticals joined forces in a deal potentially worth over US$ 2 billion to develop a new class of psychedelic compounds for psychiatric conditions, combining AbbVie’s psychiatric expertise with Gilgamesh’s innovative neuroplastogen research platform.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Our viewDuring this year, companies like Novartis (with US$ 16.8 billion), GSK (US$ 14.5 billion), Sanofi (US$ 11.9 billion), Bristol Myers Squibb (US$ 11.6 billion), and AbbVie (US$ 9.1 billion) have made substantial investments in acquisitions, collaborations and other forms of dealmaking.Though the deal-making environment is robust, we notice a shift towards mid-size transactions. Alongside, we notice a growing interest in areas such as ADCs, radiopharmaceuticals, and protein-based immunotherapies, underscoring their growing importance in drug development. There has also been significant interest in silencing RNA (siRNA) therapeutics, highlighting the industry's focus on novel approaches to disease treatment. With the industry focusing on cutting-edge technologies that address unmet medical needs, we feel there is little reason to fret over the size of the deals.

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22 Aug 2024

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FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder). Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period. Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.

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11 Jul 2024

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FDA steps in to address challenges faced by cell and gene therapies

The year 2023 was a rather tough one for cell and gene therapy (CGT) companies. There was news about smaller CGT players finding it difficult to get finance, with many drastically downsizing their operations by laying off hundreds of employees. Many others had to shut shop, making us wonder if innovation in the biopharma industry is in for a setback.The new year began on a sour note, with the FDA shooting off letters to six manufacturers of cancer therapies that use CAR-T technology to add a boxed warning on their label after the agency found a serious risk of developing secondary cancer. These therapies include Bristol-Myers Squibb’s Abecma and Breyanzi, Janssen Biotech’s Carvykti, Gilead’s Yescarta, Novartis’ Kymriah and Kite Pharma’s Tecartus. “Boxed warnings” or “black box warnings” are the highest safety warnings. A week later, FDA stepped in and finalized guidance for companies and academic researchers working on CAR-T cell therapies.In this article, PharmaCompass looks at some of the challenges being faced by CGT firms, and the growth prospects of this sunrise sector.A field with complex manufacturing, high costs of developmentThere are several ways in which CGTs can target a disease, giving rise to various kinds of such therapies. These include gene addition, gene silencing, gene editing, DNA therapy (such as DNA plasmids and viral vectors), RNA therapy (ribosomal RNA, messenger RNA, microRNA, small interfering RNA and transfer RNA), antisense oligonucleotides and gene-modified cell therapy (such as CAR T-cell therapies and Treg cell therapies). CGTs are being deployed to treat several kinds of diseases, such as various types of cancers, including brain tumors, breast and colon cancers, as well as leukemia. Other major therapeutic areas CGTs are making an impact on are genetic and rare diseases like sickle cell disease (SCD), β-thalassemia, hemophilias, and paraplegia. CGTs are also being explored for treating Duchenne muscular dystrophy, Alzheimer's disease, Parkinson’s disease, multiple sclerosis, type 1 diabetes and macular edema.Going by FDA’s Purple Book, there are 35 CGT products approved in the US. With three FDA approvals, bluebird bio tops the list (with Lyfgenia, Zynteglo, and Skysona), followed by Bristol Myers Squibb (with Abecma and Breyanzi), Kite Pharma (with Tecartus and Yescarta), and Novartis (with Zolgensma and Kymriah). Recently, FDA approved Vertex Pharma-CRISPR Therapeutics’ Casgevy, the first gene-editing therapy that uses the Nobel-prize-winning CRISPR technology.Though CGTs are personalized therapies, they come with potential risks, such as developing certain kinds of cancers, genotoxicity, allergic reactions, damage to the organs etc.Another challenge faced by CGTs is costs. Apart from the high R&D costs, these biotechs face other challenges such as high costs of reagents like clinical-grade lentiviral vectors or gene editing reagents, as well as cell processing materials, GMP facilities and personnel costs.Little wonder then that the selling price of some of the CGTs run into millions of dollars. CSL Behring and uniQure’s Hemgenix, a first-of-its-kind drug for hemophilia B, is the most expensive drug in the world. It costs a whopping US$ 3.5 million. Similarly, bluebird bio’s Lyfgenia, a therapy that has the potential to resolve vaso-occlusive events and is custom-designed to treat the underlying cause of SCD, costs US$ 3.1 million.Smaller CGT firms get strapped for funds, fail to land Big Pharma dealsTypically, innovation for CGTs happens at small biotechs or universities. Many of the small firms get acquired by bigger drugmakers or tie up with larger pharma companies so that volumes can be scaled up once the therapy is approved.Last year, scores of biotechs announced bankruptcies. Many smaller biotechs failed to land Big Pharma deals. They had to contend with narrower funding options, forcing several startups in the sector to shut shop. For example, Intergalactic Therapeutics shut down last year, after being around for less than two years. The company said: “The current environment has led to challenging times for companies to raise capital,” even though Intergalactic’s programs have “shown promise”. Other CGT firms that shut shop last year were Locanabio, Vedere Bio II and CODA Biotherapeutics.Companies that laid off employees to cut costs are base editing biotech Beam Therapeutics, Editas Medicine, Sangamo Therapeutics, Graphite Bio, UniQure, Generation Bio, Candel Therapeutics, Lyell Immunopharma, BrainStorm Cell Therapeutics and Nkarta. CRISPR Therapeutics, ElevateBio and Atsena also reportedly laid off employees. FDA lines up initiatives, to make 2024 ‘breakout’ year for gene therapiesThe “personalized nature” of CGTs makes them highly effective. But this trait also gives rise to multiple challenges. Acknowledging this, in January, FDA announced a pilot program called Collaboration on Gene Therapies Global Pilot (CoGenT Global) to streamline regulations pertaining to this sector. The agency has also addressed challenges such as the high cost of manufacturing, clinical development timelines, macroeconomic conditions (such as high interest rates), and operational issues being faced by CGTs. FDA is promising to make 2024 a “breakout” year for gene therapies, with a number of initiatives to promote clinical development, approvals and uptake. FDA’s Center for Biologics Evaluation and Research (CBER) is sponsoring research and encouraging collaboration with the National Institutes of Health’s Bespoke Gene Therapy Consortium. The agency has made gene editing therapies eligible for accelerated approval and detailed the information that should be provided in an investigational new drug (IND) application. It has also launched a pilot program Support for clinical Trials Advancing Rare disease Therapeutics (START), with the intention of speeding up development.Our viewIn 2022, Precedence Research estimated the CGT market at US$ 15.46 billion, expecting it to increase fivefold by 2032 to touch US$ 82.24 billion, with therapeutic areas such as oncology (US$ 10.4 billion) and genetic disorders (US$ 8.57 billion) expected to draw most revenues.FDA approved seven CGTs in 2023, including Casgevy. But this year, FDA and European regulators may approve as many as 17 gene therapies. A McKinsey report says in 2024 alone, “up to 21 cell therapy launches and as many as 31 gene therapy launches—including more than 29 adeno-associated virus (AAV) therapies—are expected.” Given these estimates, we have little doubt that 2024 will be a “breakout year” for CGTs.

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22 Feb 2024

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Top Pharma Companies & Drugs in 2021: Covid vaccines, pills cause churn in list

Every year, the list of top pharmaceutical products and companies by sales sees some churn. But the year 2021 was a lot different — it saw the pharma industry landscape change dramatically. It was a year when the industry was busy developing vaccines and therapies so that the world could recover from the Covid-19 pandemic. And this resulted in many drugmakers raking in billions of dollars in sales. As a result, the top company of 2020 in terms of pharmaceutical sales — Roche — slipped to the number five spot, while Pfizer, which was at number eight in 2020 after spinning off its generic business, moved up to the number one slot. The year proved to be a good one for pharmaceutical companies. Interestingly, last year none of the top 20 pharmaceutical companies saw a decline in their revenue. View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) Pfizer’s Comirnaty steals the show The company that reaped the maximum gains from its Covid vaccine was Pfizer. Comirnaty (tozinameran) was the top selling pharmaceutical product of 2021, posting global revenues of US$ 36.8 billion. This messenger-RNA Covid-19 vaccine, developed along with its German partner BioNTech, catapulted Pfizer to the slot of the top company by sales in 2021. Pfizer’s global topline grew from US$ 41.7 billion in 2020 to US$ 81.3 billion in 2021. In 2020, Pfizer was at number eight, behind Roche, Novartis, GSK, AbbVie, J&J, Merck and BMS. In 2021, it took a lead of billions of dollars on all these companies. The second largest drug company by sales — AbbVie — was way down at US$ 56.1 billion in global revenues. In fact, Comirnaty has become the fastest-selling drug in the history of the pharmaceutical industry. Back in December 2020, when both Comirnaty and Moderna’s Spikevax had bagged the US Food and Drug Administration’s emergency use authorization (EUA), there was a lot of uncertainty around how the promised doses would be delivered across the world. But both Comirnaty and Spikevax have proven to be a resounding success. Spikevax emerged as the third largest selling pharmaceutical product of 2021, bringing in US$ 17.7 billion for Moderna. Analysts expect both Pfizer-BioNTech and Moderna to sell even more vaccines in 2022. The reasons are manifold. First, SARS-CoV-2 is able to mutate often, and is unlikely to be eradicated in the near future, creating a need for booster shots. Second, the younger age groups are still to get vaccinated. Along with Comirnaty, Pfizer is battling Covid-19 with its antiviral pill, Paxlovid. Though the sales of Paxlovid have nosedived of late, Pfizer expects Comirnaty and Paxlovid to help the New York-headquartered drug behemoth achieve US$ 100 billion in 2022 revenues. View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) AbbVie moves up, sans Covid product; Roche slips to number five With no Covid-19 related products, AbbVie did fairly well in 2021 — it moved up from the number four spot in 2020 to number two position, thanks to its Allergan acquisition, cash cow Humira (adalimumab), the continued success of its cancer drug Imbruvica (ibrutinib) and an increase in sale of its psoriasis treatment Skyrizi (risankizumab) by a whopping 85 percent in 2021. Humira brought in sales of US$ 21.2 billion for AbbVie in 2021. However, things may change soon, with biosimilars of Humira slated to enter the market in 2023. The years 2022 and 2023 are likely to be transition years for AbbVie, as it works to build the market for its Humira successors — Rinvoq and Skyrizi. Roche emerged as a big loser in 2021, as several copycats of its blockbuster drugs hit the market. Copycats to Roche’s three blockbuster cancer drugs—Avastin, Herceptin and Rituxan—eroded US$ 4.9 billion (CHF 4.73 billion) from the company’s sales in 2021. A large chunk of growth for Roche came from its multiple sclerosis med Ocrevus, hemophilia drug Hemlibra, inflammatory disease therapy Actemra and PD-L1 inhibitor Tecentriq. The pandemic resulted in lower-than-expected sales of Ocrevus (ocrelizumab) due to fears around its immunosuppressive effects. Like Roche, Novartis also slipped last year. It fell from number two in 2020 to the number four slot in 2021. Essentially, Novartis is struggling with a relatively lackluster pipeline. It had sold its 33 percent stake in Roche last year for US$ 20.7 billion. It plans to use that sum for acquisitions in order to beef up its pipeline. The Swiss drugmaker has also drawn up a restructuring plan that includes layoffs of thousands of employees. Before the pandemic, Merck’s Keytruda was touted as the drug that would overtake Humira at the top in 2024. The checkpoint inhibitor has continued to grow impressively, adding new indications and treatment lines. Keytruda is now used in close to 40 indications. With US$ 17.2 billion in sales, Keytruda emerged as the fourth largest selling drug of 2022. Overall though, Merck slipped from number six to the number eight slot. This was due to the fact that Merck had spun out its women’s health, biosimilars and established brands businesses into Organon. However, its Covid-19 antiviral pill — Molnupiravir — was able to compensate for the lost revenue. Though the FDA is yet to grant the drug a full approval (it bagged an EUA in December 2021), advance sales agreements helped it rack up US$ 952 million in sales in the fourth quarter. View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) BMS moves up with Eliquis, Revlimid; J&J lands at number three Bristol Myers Squibb (BMS) moved up from number seven in 2020 to number six, thanks to two of its drugs that made it to top 10 — anticoagulant Eliquis at number five and oncology drug Revlimid at number six. However, Revlimid will soon face competition — four generic companies now have the approval to sell their versions of Revlimid (lenalidomide) after March 2022. Revlimid sales are expected to drop from US$ 12.9 billion to just US$ 2.06 billion in 2026. BMS posted US$ 46.4 billion in global revenues, a nine percent increase from US$ 42.5 billion reported in 2020. In immuno-oncology, Opdivo brought in US$ 7.52 billion in sales, while Yervoy drew in sales of US$ 2 billion (an increase of 20 percent). J&J’s pharma division brought in US$ 52.1 billion in revenues last year, an increase of 14 percent over its revenues of US$ 45.6 billion posted in 2020. Drugs like Darzalex (for multiple myeloma), Stelara and its Covid-19 vaccine brought in growth during 2021, helping J&J move up from number five to the number three slot. J&J’s Covid-19 vaccine brought in US$ 2.4 billion in sales. View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) GSK bags approval for shingles vaccine; Takeda suffers setbacks GlaxoSmithKline (GSK) slipped four places — from number three in 2020 to number seven in 2021. Though GSK did not have a drug in the top 10, sales of GSK and Vir Biotechnology’s Covid-19 antibody treatment sotrovimab helped produce a seven percent increase in its 2021 revenue. The British drugmaker also bagged a critical FDA approval — its vaccine to prevent shingles (herpes zoster), Shingrix, bagged the agency’s nod in July. GSK hopes to double the sales of Shingrix by 2026. GSK is also undergoing a major transformation, and plans to demerge its consumer health unit this year. The unit generated revenues of £9.6 billion (US$ 13 billion) last year, and GSK sees the demerger as a necessary step to fuel growth through the development of new vaccines and specialty medicines. Sanofi managed to retain its ninth slot, even as its global turnover increased from US$ 39.3 billion (Euro 36.04 billion) to US$ 41.6 billion (Euro 37.76 billion). It snapped up Kymab, Tidal Therapeutics, Translate Bio, Kadmon Holdings, Origimm Biotechnology and Amunix in deals that bolstered its presence in immunology, immuno-oncology and vaccines. Dealmaking is on the French drugmaker’s menu for 2022 and beyond, Sanofi’s CFO said at this year’s virtual JP Morgan Healthcare Conference. AstraZeneca’s global revenues grew from US$ 26.6 billion in 2020 to US$ 37.4 billion in 2021. However, its rank fell from nine in 2020 to 10 in 2021. AstraZeneca wrapped up the US$ 39 billion acquisition of Alexion in July 2021. Alexion’s rare disease franchise—led by C5 inhibitors Soliris and Ultomiris—added an extra US$ 3.1 billion to Astra’s top line last year. Takeda suffered several clinical and regulatory setbacks in 2021, which it labeled as an “inflection year.” For Gilead, sales of its Covid-19 antiviral Veklury brought in US$ 5.6 billion last year, helping its revenues grow by 11 percent. View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) Our view If anything, the pandemic has taught us that change is the only constant. It has also taught us that products can become blockbusters in a matter of a few months. The industry landscape continues to change. On the one hand, we are seeing people scrambling to get Covid vaccines and booster shots, on the other hand, the FDA has limited the use of monoclonal antibodies, such as Eli Lilly’s bamlanivimab and etesevimab and Regeneron’s REGEN-COV (casirivimab and imdevimab), in treating Covid caused by the Omicron variant. The FDA has also pulled the authorization granted to GSK and Vir Biotechnology’s antibody therapy this month, citing data that suggested it was unlikely to be effective against the dominant Omicron sub-variant. And last week, there was news that demand for Pfizer’s antiviral pill Paxlovid has remained unexpectedly low. The supply of Paxlovid, which reduced hospitalizations or deaths in high-risk patients by around 90 percent in a clinical trial, has far outstripped demand in many countries like the US, the UK and South Korea. Though Pfizer is hopeful of crossing US$ 100 billion in revenue this year, much depends on how the pandemic pans out and what new research has to say about the novel coronavirus. A lot will change once the pandemic becomes endemic. The first four months of 2022 tell us that vaccines like Comirnaty and Spikevax will continue to perform well. But two years down the line, our charts could look very different.

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28 Apr 2022

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Top drugs and pharma companies by sales in 2020

Last year, the pandemic impacted everyone’s life in one way or the other. It turned the limelight on to the pharmaceutical industry, which stepped up efforts to deliver treatments and vaccines for Covid-19. It was a year of challenges for the drug industry as it struggled to supply existing drugs and treat emergencies amid disruptions in the way business was conducted the world over. Unlike previous years when the top five drug companies largely remained unchanged, 2020 saw several movers and shakers. The acquisition of Allergan by AbbVie helped it enter the ‘top five’ list, while companies like Pfizer and Merck got edged out. Despite a 2 percent increase in revenues, Pfizer dropping out of the top five was not a complete surprise as it spun-off its Upjohn unit. The unit merged with Mylan to create Viatris, an entity with over US $10 billion in revenues. View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available) Roche emerges as top drug company by global sales The top five list of global pharmaceutical companies by sales in 2020 was quite a mix of surprises. While Swiss major Roche topped the ranking of global drug companies by pharmaceutical sales (with global revenues of US$ 49.6 billion or CHF 44.532 billion), it also witnessed a sales decline of 8 percent, which was partially an outcome of the Swiss franc gaining against most currencies during the pandemic. Overall, competition from biosimilars and the Covid-19 pandemic had a negative impact on Roche’s pharmaceutical sales in 2020. However, it witnessed strong sales growth of newly launched medicines like Tecentriq, Hemlibra, Ocrevus, Perjeta and Kadcyla, which helped in offsetting the CHF 5 billion (US$ 5.53 billion) impact of competition from biosimilars. At the second position was Swiss drugmaker Novartis, whose global sales (at US$ 48.7 billion) were marginally lower than Roche’s. Unlike the numero uno, Novartis’ pharmaceutical sales grew 4 percent, driven by cardiology drug Entresto that witnessed a 44 percent increase in revenues. While its oncology unit and Sandoz’s biosimilars business also posted an increase in sales, Covid-19 negatively impacted demand, particularly for the company’s ophthalmology and dermatology operations and the retail operations of Sandoz. The year also saw Novartis’ gene therapy Zolgensma, the world’s costliest drug, reach nearly US$ 1 billion in sales. As the British pound became a lot stronger against the US dollar, GlaxoSmithKline Plc (GSK) witnessed a 3 percent increase in sales in constant currency terms and saw its group sales (£ 34.1 billion or US$ 47.27 billion) take the number three spot in US dollar terms. Strong sales performances from key growth drivers in HIV, respiratory, oncology and consumer healthcare offset disruptions from Covid-19. GSK’s consumer healthcare division reported over £10 billion (US$ 13.91 billion) in sales and the firm is on track to create new standalone biopharma and consumer healthcare companies in 2022. View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available) AbbVie’s international Humira sales drop 13.6% due to biosimilars AbbVie reported worldwide revenues of US$ 45.8 billion, an increase of 38 percent versus the previous year. This included US$ 10.3 billion in revenues from the Allergan acquisition, growth in the immunology portfolio, and the continued strength of Humira in the US as well as revenue growth from Imbruvica and Venclexta. Humira, the best-selling drug since 2012, continued to dominate with US$ 19.83 billion in sales, an increase of 3.5 percent as compared to 2019. While the international sales of Humira dropped 13.6 percent due to competition from biosimilars, in the US sales increased as Humira is protected from biosimilar competition until 2023. J&J’s pharmaceutical division delivered a strong performance as its pharmaceutical sales grew 8 percent to US$ 45.6 billion and contributed more than the combined sales of its other two units — consumer health and medical devices. This sales growth was largely attributed to primary operational drivers including Imbruvica and Stelara, which were among the top 10 drugs by sales in 2020. J&J and AbbVie have an equal share in the profits (and losses) from the sales of Imbruvica, which witnessed a double digit increase in sales to US$ 9.4 billion. Similarly, J&J’s Stelara reached US$ 8.0 billion in sales. J&J’s overall revenues grew by just 0.6 percent to US$ 82.6 billion (including sales from its consumer health and medical devices divisions). It will be interesting to see what J&J’s 2021 revenues look like as it benefits from the sales of its single-dose Covid-19 vaccine. View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available) Merck’s Keytruda on its way to becoming world’s best-seller With AbbVie’s Humira beginning to face generic competition, Merck’s oncology drug Keytruda continued to go from strength to strength posting a sales growth of 30 percent. Keytruda delivered more than US$ 14.4 billion in sales, almost a third of the firm’s US$ 43 billion revenue. It’s only a matter of time before Keytruda becomes the world’s best-selling drug. Bristol Myers Squibb (BMS) reported worldwide revenues of US$ 42.5 billion in 2020. BMS’ products Revlimid and Eliquis reported significant growth last year, and followed Humira and Keytruda in terms of sales. Eliquis, which is also promoted by Pfizer in some geographies, had total sales of US$ 14.1 billion while Revlimid posted over US$ 12 billion in sales. Revlimid, which BMS picked up through its acquisition of Celgene, will face limited generic competition sometime after March 2022. Furthermore, while BMS’ oncology treatment Opdivo’s sales (US$ 7.2 billion) declined by 3 percent compared to 2019, it remained one of the top selling drugs in 2020 (US$ 7.9 billion) with a small portion of sales coming from Ono Pharma in Japan. Sanofi reported approximately US$ 43.6 billion (€36 billion) in net sales for 2020, which rose by 3.3 percent at constant exchange rates even as some of its flagship products’ sales declined due to generic and biosimilar competition. Solid performances from Dupixent, vaccines and its specialty care global business unit across all geographies, more than offset lower sales. In the case of Gilead, while products like Biktarvy in its HIV portfolio witnessed a growth of over 50 percent to more than US$ 6 billion, it was Gilead’s treatment for Covid-19 — remdesivir — promoted under the brand Veklury which went from no sales in 2019 to US$ 2.81 billion in sales in 2020. View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available) Our view The human health business of many companies was negatively impacted by the Covid-19 pandemic. However, operating expenses saw a reduction due to lower promotional and selling costs, as well as lower R&D expenses. This year, as Covid vaccines from Pfizer, Moderna, J&J and AstraZeneca are rolled out in more countries across the world, they are expected to ring in significant revenue contributions for these companies. For instance, Pfizer recently announced that it expects US$ 26 billion in revenues from the sale of its vaccine in 2021. Similarly, Moderna said it expects US$ 19.2 billion in sales from its Covid-19 vaccine this year. Given this scenario, the order of the top drug companies and the sales contribution of various drugs will change significantly in 2021. It seems likely that Pfizer’s vaccine will become the best-selling product by sales in 2021 and the American drugmaker will be back among the top five in the global drug companies by sales list. View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)

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13 May 2021

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Top 15 Pharmaceutical Companies by Drug Sales in 2016

In 2016, M&A deals fell drastically in both numbers and value. One key reason was the falling through of the Pfizer-Allergan mega merger due to America’s crack down on inversion deals. The year 2015 went down in history as a record year for mergers and acquisitions (M&As) in the pharmaceutical and biotech space, when deals worth US $ 300 billion were announced. The highlight of 2015 was the mega-merger announced between US drugmaker Pfizer and Ireland-based Allergan – the biggest-ever pharma transaction that was worth more than US$ 160 billion. 2016 saw Pfizer and Allergan walk away from their US$ 160 billion merger when the new US Treasury rules cracked down on inversion deals that were encouraging US companies to move overseas to cut taxes. The merger would have allowed New York-based Pfizer to cut its tax bill by an estimated US$ 1 billion annually by domiciling in Ireland, where tax rates are lower. M&A deals dip by 20 percent in 2016 Although the Pfizer-Allergan mega-merger did not go through, The Pharma Letter tracked transactions through the year and noted that although “worldwide merger and acquisition activity in the pharmaceutical and biotechnology sector in 2016 was plentiful”, the numbers and values were “well down” on those seen in the previous two years. The number of transactions announced in 2016 was 130, compared to 166 M&A deals in 2015 – which was a record year – and 137 in 2014, says The Pharma Letter. Values of the top 10 deals drop to a third The other crucial fact about M&A deals in 2016 was that transactions that exceeded the US$ 1 billion mark were down to just 23 in 2016, as against 30 in 2015 and 26 in 2014. The Pharma Letter quotes a KPMG report published earlier this year which notes that the total value of the top 10 completed deals in the first half of 2016 amounted to US $ 67.2 billion as opposed to US $190.4 billion in first-half 2015. Sanofi-Actelion — the deal that wasn’t Sanofi made headlines, not for the acquisitions it made, but for the ones it wasn’t able to close. Late last year, the French pharma giant was widely identified as the big player that managed to push Johnson & Johnson away from negotiations with Actelion only to lose its US$ 30 billion bid to J&J even though it would have delivered “approximately equivalent value to Actelion’s shareholders”. The Actelion loss came after Sanofi was out bid by Pfizer for Medivation. Pfizer agreed to buy the US cancer drug company for US$ 14 billion in cash, adding its blockbuster prostate cancer drug Xtandi to the company's growing oncology roster. Additionally, Pfizer acquired Anacor for US$ 5.2 billion to add an eczema gel to its portfolio. Bayer’s US$ 66 billion takeover The biggest deal announced in 2016 was Bayer’s US$ 66 billion takeover of the US seeds company Monsanto after months of wrangling. It was the German drug and crop-chemical company’s third offer that clinched the deal, which is also known to be the largest all-cash deal on record. This signature deal has disrupted the agribusiness sector, which in recent years has been involved in a consolidation race largely triggered by factors such as shifting weather patterns, intense competition in grain exports and a souring global farm economy. Top pharma companies by sales Bayer’s acquisition of Monsanto makes the ranking of top pharmaceutical companies consistently complicated since Bayer will generate more sales from its crop science and high-tech polymer division than from the sale of prescription drugs. Should divisions like diagnostics, animal health, vaccines, consumer health be counted while determining the size of a pharmaceutical company? In a volatile global world, where wild exchange rate fluctuations play their own major role in determining the size of organizations, this week PharmaCompass shares the revenues, as presented in the 2016 annual reports of top 15 companies, so that you can draw your own conclusions on the top drug companies of the world. Company Name Currency Pharma Consumer Health Medical Devices/ Diagnostics Vaccines Animal Health Other Revenues Total Sales 1 Pfizer USD 41,600 3,407 6,071 1,746 52,824 2 Novartis USD 48,518 48,518 3 Roche CHF 41,047 11,589 52,636 4 Merck & Co. USD 29,360 5,791 3,478 1,178 39,807 5 GlaxoSmithKline GBP 16,104 7,193 4,592 27,889 6 Johnson & Johnson USD 33,464 13,307 25,119 71,890 7 Sanofi EUR 22,932 3,330 4,577 2,708 274 33,821 8 Gilead USD 29,953 437 30,390 9 Abbvie USD 25,560 78 25,638 10 Bayer EUR 16,420 6,037 1,523 22,789 46,769 11 Amgen USD 21,892 1,099 22,991 12 Astrazeneca USD 21,319 1,683 23,002 13 Teva USD 20,664 1,239 21,903 14 Eli Lilly USD 18,064 3,158 21,222 15 Bristol-Myers Squibb USD 17,702 1,725 19,427 Sales figures are reported in millions. Currency exchange rate used CHF: 0.99 USD/ EUR: 1.06 USD / GBP: 1.25 USD Ranking methodology When it came to ranking companies, based on their total sales, we at PharmaCompass did not face any challenges while including the sales of prescription drugs along with those of vaccines. But matters got a little complicated when we got down to ranking consumer health divisions. For instance, while we have included consumer health divisions of companies like Sanofi, GSK and Bayer, which primarily sell OTC drug products (such as brands like Allegra, Voltaren and Aleve), we have excluded those of companies like Johnson & Johnson, given their focus on baby and beauty products. Such a demarcation — based on the focus of the company — will always be a matter of debate. Similarly, revenue generated from the sale of medical devices/diagnostics as well as revenues of animal health divisions were not included in our rankings. In the case of companies like Bayer, whose Covestro’s division has over US$ 10 billion in sales from customer industries such as automotive, construction, electrical and electronics, and furniture, such sales were accounted for in ‘other revenues’. Our table highlights the sales revenue of various divisions of companies in order to bring more clarity into the figures which were included in our rankings.

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02 Mar 2017

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